J&J Sold Vaginal Mesh Implant After Sales Halt Ordered

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. Photographer: Daniel Acker/Bloomberg

June 26 (Bloomberg) -- Johnson & Johnson, the biggest
health-care products maker, continued to sell a vaginal mesh
implant for nine months after U.S. regulators told the company
to stop marketing the device, according to court records.

The U.S. Food and Drug Administration told J&J in a letter
on Aug. 24, 2007, to halt Gynecare Prolift sales until the
agency decided whether the device was “substantially
equivalent” to other products on the market. The FDA cited the
“potential high risk for organ perforation” when surgeons
insert the mesh vaginally to support weakened pelvic tissue.

“You may not market this device until you have provided
adequate information” on 16 potential deficiencies and received
FDA approval, the agency told New Brunswick, New Jersey-based
J&J in the letter. “If you market the device without conforming
to these requirements, you will be in violation of the Federal
Food, Drug and Cosmetic Act.”

The FDA cleared the device in May 2008 without ordering
sanctions, after nine months of negotiations with J&J’s Ethicon
unit. The company faces more than 1,400 lawsuits by women who
said the mesh caused organ perforation, pain, scarring and nerve
damage. Lawyers for the women said the device’s approval history
could increase J&J’s cost to resolve the litigation.

“If a company knows the FDA tells them, ‘Don’t sell a
device,’ they’re supposed to not sell it,” Adam Slater, an
attorney suing on behalf of 150 women, said in a phone
interview. “It’s egregious that J&J was selling the device
without clearance.”

Letter Unsealed

The 2007 letter was part of a group of documents filed
under seal in state court in Atlantic City, New Jersey, and made
public in May at the request of Slater, a partner at Mazie
Slater Katz & Freeman LLC in Roseland, New Jersey. Lawsuits also
are pending in federal court in Charleston, West Virginia.

J&J began selling the Prolift in 2005 without filing a new
application after determining on its own that it was
substantially similar to the Gynemesh, a company device already
approved by the FDA, said Matthew Johnson, a J&J spokesman, in
an e-mail. The device maker relied on FDA guidance for when
companies must submit new applications, Johnson said.

The FDA disagreed with J&J’s interpretation and required a
new application that prompted questions in the August 2007
letter, Morgan Liscinsky, an agency spokeswoman, said in an e-mail.

J&J faced no sanctions because the FDA determined that the
company applied the guidance in good faith and it “promptly
complied” when the agency required a new application, Liscinsky
said.

Fines, Injunctions

Sanctions for selling products without approval may include
fines, injunctions against a company or senior managers and the
seizure of illegally marketed devices, Liscinsky said.

The August 2007 letter was “only one part of an extended
dialogue with FDA in 2007-08, and it is out of context,”
Johnson said in the e-mail. “Throughout this process, our
actions were responsible, appropriate and consistent with FDA
regulations.”

Henry G. Garrard III, a lawyer who represents women suing
in federal court in Charleston, said the FDA’s failure to take
additional steps to halt Prolift sales or to sanction J&J raises
questions about the agency’s power to protect patients.

“Every woman in America who has been implanted with these
devices absolutely should be outraged,” he said. “They should
be mad at the company because the company knew they could get
away with it.”

‘Water Pistol’

The Prolift negotiations point out “the industry’s ability
to shrug off FDA enforcement,” said Erik Gordon, a business
professor at the University of Michigan, in an e-mail. “If
companies can get away with selling products they aren’t
supposed to sell, the FDA is a sheriff packing a water pistol.”

The U.S. Senate is to vote today on changes to the FDA’s
device-review system, which has drawn scrutiny for allowing
implants like vaginal mesh on the market without human testing.

The bill increases funding for reviews and the FDA’s power
to order safety studies after a product is cleared. It doesn’t
include powers sought by consumer groups to let the FDA require
clinical trials for more implants before they reach the market.
The House of Representatives approved the measure last week.

Implants Threaded

Surgeons thread mesh implants through vaginal incisions and
use the devices to treat incontinence or pelvic organ prolapse,
a condition in which weakened muscles fail to support organs.
Almost 300,000 were used in U.S. women in 2010, the FDA
estimated last year.

An FDA database of reported malfunctions, deaths and
serious injuries shows the agency received 123 complaints about
the Prolift from 2005 to May 15, 2008, when the device won
clearance. The company said in a September 2007 letter to
regulators that reported problems accounted for less than 0.5
percent of sales for both Gynemesh and Prolift.

An agency report in July found a fivefold jump in deaths,
injuries or malfunctions tied to prolapse mesh inserted
vaginally. In January, the FDA ordered J&J, Murray Hill, New
Jersey-based C.R. Bard Inc. and other manufacturers to study
organ damage and complications related to the products.

Sales Estimates

Manufacturers including J&J sold about $175 million worth
of prolapse mesh worldwide and another $295 million for
incontinence treatments in 2010, C.R. Bard executives estimated
on a conference call that year. Even for top sellers of the
devices, the products made up no more than 2 percent of company
sales, said Michael Matson, a Mizuho Securities USA analyst in
New York.

The numbers declined as lawsuits were filed, he said in a
telephone interview.

On June 5, J&J said it will stop selling four vaginal mesh
implants including the Prolift. The move wasn’t a recall and J&J
remains confident in the safety and effectiveness of the
devices, Johnson said. The company won’t withdraw the Prolift
before its “planned discontinuation” of the mesh products over
the next three to nine months, he said.

“Our decision to discontinue these products is based on
their commercial viability in light of changing market
dynamics,” he said.

Label Update

In letters to state and federal judges, the company said
that it will update labeling for one device, the Gynemesh, to
allow only abdominal, not vaginal, insertion.

The FDA learned of the Prolift after J&J cited it in an
application to sell a related device, the Prolift+M, Liscinsky
said. The agency told J&J to file for the Prolift as well, and
it combined the review for both devices before the August 2007
letter.

“Due to the complexity of this procedure and potential
high risk for organ perforation, bench testing is not sufficient
to demonstrate device safety and efficacy,” the FDA said in the
letter. Bench testing refers to laboratory testing to determine
how a device will function in a person.

In the August 2007 letter, the FDA asked 16 questions about
the Gynemesh and Prolift, which are made of the same
nonabsorbable polymer. The Prolift kit includes pre-shaped mesh
and instruments to help surgeons implant the device.

Complications

One FDA query was about a “significant number” of
complications from 2004 to 2007 on the earlier device, the
Gynemesh. The agency got 174 such reports, including for
infection, abscess and organ perforation. Most of the cases
required additional surgery.

The agency’s letter also found that labeling for the
Prolift+M device was deficient because it couldn’t support
claims that the mesh has “elastic properties that allow
adaptation to physiological stresses.” In its response, J&J
agreed to remove that claim.

Many of the documents unsealed last month include e-mails
between J&J and the FDA over the wording of product labeling
about the benefits and risks.

Six days before the FDA cleared the Prolift, J&J agreed in
a written response to say in the label that the safety and
effectiveness of the device, compared to conventional surgical
repair without mesh, “have not been demonstrated in randomized
controlled clinical trials.”

Rather, J&J wrote, the substantial equivalence to earlier
approved devices had been demonstrated through other tests.

The federal cases are In re Ethicon Inc., Pelvic Repair
System Products Liability Litigation, 12-md-02327, U.S. District
Court, Southern District of West Virginia (Charleston).